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HHS/FDA RIN: 0910-AG35 Publication ID: Fall 2015 
Title: Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption  
Abstract:

This rule will establish science-based minimum standards for the safe production and harvesting of those types of fruits and vegetables that are raw agricultural commodities for which the Secretary has determined that such standards minimize the risk of serious adverse health consequences or death. The purpose of the rule is to reduce the risk of illness associated with fresh produce.

 
Agency: Department of Health and Human Services(HHS)  Priority: Economically Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: Yes  Unfunded Mandates: Private Sector 
EO 13771 Designation: uncollected 
CFR Citation: 21 CFR 112   
Legal Authority: 21 U.S.C. 342    21 U.S.C. 350h    21 U.S.C. 371    42 U.S.C. 264    Pub. L. 111-353 (signed on January 4, 2011)   
Legal Deadline:
Action Source Description Date
Final  Judicial  To the Office of the Federal Register for publication.  10/31/2015 

Statement of Need:

FDA is taking this action to meet the requirements of the Food Safety Moderhnization Act (FSMA)and to address the food safety challenges associated with fresh produce and, thereby, protect the public health. Data indicate that between 1973 and 1997, outbreaks of foodborne illness in the U.S. associated with fresh produce increased in absolute numbers and as a proportion of all reported foodborne illness outbreaks. The Agency issued general good agricultural practice guidelines for fresh fruits and vegetables over a decade ago. Incorporating prevention-oriented public health principles, and incorporating what we have learned in the past decade into a regulation is a critical step in establishing standards for the production and harvesting of produce, and reducing the foodborne illness attributed to fresh produce.

Summary of the Legal Basis:

FDA is relying on the amendments to the Federal Food, Drug, and Cosmetic Act (the FD&C Act), provided by section 105 of the FSMA (codified primarily in section 419 of the FD&C Act (21 U.S.C. 350h)). FDA's legal basis also derives in part from sections 402(a)(3), 402(a)(4), and 701(a) of the FD&C Act (21 U.S.C. 342(a)(3), 342(a)(4), and 371(a)). FDA also intends to rely on section 361 of the Public Health Service Act (PHS Act) (42 U.S.C. 264), which gives FDA authority to promulgate regulations to control the spread of communicable disease.

Alternatives:

Section 105 of the FSMA requires FDA to conduct this rulemaking.

Anticipated Costs and Benefits:

FDA estimates that the costs to more than 300,000 domestic and foreign producers and packers of fresh produce from the proposal would include one-time costs (e.g., new tools and equipment) and recurring costs (e.g., monitoring, training, recordkeeping). FDA anticipates that the benefits would be a reduction in foodborne illness and deaths associated with fresh produce. The monetized annual benefits of this rule are estimated to be $1 billion, and the monetized annual costs are estimated to be $460 million, domestically.

Risks:

This regulation would directly and materially advance the Federal Government's substantial interest in reducing the risks for illness and death associated with foodborne infections associated with the consumption of fresh produce. Less restrictive and less comprehensive approaches have not been sufficiently effective in reducing the problems addressed by this regulation. FDA anticipates that the regulation would lead to a significant decrease in foodborne illness associated with fresh produce consumed in the United States.

Timetable:
Action Date FR Cite
NPRM  01/16/2013  78 FR 3503   
NPRM Comment Period End  05/16/2013 
NPRM Comment Period Extended  04/26/2013  78 FR 24692   
NPRM Comment Period Extended End  09/16/2013 
NPRM Comment Period Extended  08/09/2013  78 FR 48637   
NPRM Comment Period Extended End  11/15/2013 
Notice of Intent To Prepare an Environmental Impact Statement for the Proposed Rule  08/19/2013  78 FR 50358   
Notice of Intent To Prepare Environmental Impact Statement for the Proposed Rule Comment Period End  11/15/2013 
NPRM Comment Period Extended  11/20/2013  78 FR 69605   
NPRM Comment Period Extended End  11/22/2013 
Environmental Impact Statement for the Proposed Rule; Comment Period Extended  03/11/2014  79 FR 13593   
Environmental Impact Statement for the Proposed Rule; Comment Period Extended End  04/18/2014 
Supplemental NPRM  09/29/2014  79 FR 58433   
Supplemental NPRM Comment Period End  12/15/2014 
Draft Environmental Impact Statement  01/14/2015  80 FR 1852   
Draft Environmental Impact Statement Comment Period End  03/13/2015 
Final Rule  11/00/2015 
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: Yes 
International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.
RIN Data Printed in the FR: Yes 
Agency Contact:
Samir Assar
Supervisory Consumer Safety Officer
Department of Health and Human Services
Food and Drug Administration
Center for Food Safety and Applied Nutrition, Office of Food Safety, 5001 Campus Drive,
College Park, MD 20740
Phone:240 402-1636
Email: samir.assar@fda.hhs.gov